Bristol Myers Squibb will boost its cell therapy manufacturing network with in-house viral vector production thanks to the acquisition of Novartis’ Libertyville, Illinois facility.
More than a year after imposing a clinical hold on MaaT Pharma’s lead microbiome therapeutic in 2021, the US Food and Drug Administration (FDA) has given clearance for the French firm to begin a phase 3 trial in the US.
Asahi Kasei Bioprocess America and GeminiBio have entered into a strategic partnership to advance the application of inline buffer formulation (IBF) in the biopharmaceutical industry.
As part of a $1 billion deal forged in 2020, Biogen has exercised the option to license a treatment candidate for Alzheimer’s disease developed by the US biotech company Denali Therapeutics. The engineered antibody drug is designed to cross into the brain...
The modification of an existing collaboration agreement with AstraZeneca gives Sanofi full commercial control of RSV antibody Beyfortus (nirsevimab) and 'enhanced agility' in the US market.
Meissner Corporation – a company which manufactures advanced microfiltration and therapeutic manufacturing systems for pharmaceutical drugs, therapeutics, biologics, and cell and gene therapies - will invest nearly $250m in a new manufacturing facility...
Moderna will expand in the US with new offices in San Francisco and Seattle: while the company also expects to hire around 2,000 new employees globally this year.
In acquiring antibody-drug conjugates technology pioneer Seagen, Pfizer eyes up the strong growth trajectories of Seagen's medicines and the potential of its pipeline and technology.
Sanofi will acquire US-based Provention Bio: gaining Tzield (teplizumab-mzwv), which was approved by the FDA last year as the first and only therapy to delay the onset of Stage 3 type 1 diabetes.
PackGene Biotech, an adeno-associated virus (AAV) vector contract research organization (CRO) and contract development and manufacturing organization (CDMO), is expanding its US services with a new cGMP biomanufacturing and processing facility in Houston....
The Danish-US biotech Hemab Therapeutics bags $135m to finance the clinical development of prophylactic treatments for genetic bleeding disorders including Glanzmann thrombasthenia and von Willebrand disease.
Biotage will acquire Astrea Bioseparations, a chromatography solutions provider, from Gamma Biosciences: extending its chromatography franchise into the bioprocessing market for biologics and advanced therapeutic customers.
New company Syena says it has the potential to create the next generation of cell therapy: combining the safety, potency and scalability of natural killer (NK) cells with the ability of T cell receptors (TCR) to target intracellular tumor antigens.
The FDA wants to simplify COVID-19 immunizations and will discuss various ideas for future immunization strategies at an advisory committee meeting this week.
An agreement between the two countries means they can use each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities and avoid the need for duplicate inspections.
NextCure and LegoChem Biosciences have announced a collaboration and co-development agreement focused on generating a B7-H4 antibody drug conjugate (ADC) and options for two additional targets.
The US Food and Drug Administration (FDA) has approved Provention Bio’s Tzield (teplizumab-mzwv) to delay the onset of stage 3 type 1 diabetes: with the American Diabetes Association welcoming it as a 'tremendous accomplishment'.
EdiGene Biotechnology USA has moved into a new Research & Development Center in Waltham, Mass. to advance its proprietary LEAPER tech into in vivo RNA editing therapies: with an initial focus on ophthalmology and the central nervous system.
AbbVie will acquire DJS Antibodies Ltd, a privately-held UK-based biotechnology company dedicated to discovering and developing antibody medicines that target difficult-to-drug disease-causing proteins.
The US National Institutes of Health plans to invest $130m in accelerating the widespread use of artificial intelligence (AI) by the biomedical and behavioral research communities through its Bridge2AI program.
The US Food and Drug Administration (FDA) has granted Accelerated Approval for bluebird bio’s Skysona (elivaldogene autotemcel), also known as eli-cel, to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral...
Arcturus Therapeutics has obtained an award for up to $63.2m from the Biomedical Advanced Research and Development Authority (BARDA): allowing the company to expand its current influenza vaccine program to include development of a pandemic influenza vaccine...
Despite continuous bioprocessing being talked about as the future of manufacturing in biologics for years, this has not become reality. However, in recent years, the US government has begun to dedicate funds to intensify the production of biologics.
ElevateBio and the University of Pittsburgh have entered into a long-term strategic partnership to accelerate the development of innovative cell and gene therapies: with ElevateBio to locate its next BaseCamp process development and GMP manufacturing...
Bavarian Nordic has entered into an agreement with Grand River Aseptic Manufacturing (GRAM), a US based contract manufacturer, for fill and finish of the Jynneos smallpox/monkeypox vaccine in the country.
The U.S. Food and Drug Administration (FDA) has approved bluebird bio’s Zynteglo (betibeglogene autotemcel), also known as beti-cel: a one-time gene therapy custom-designed to treat the underlying genetic cause of beta thalassemia in adult and pediatric...
Biomanufacturing company National Resilience has announced a strategic collaboration with Mayo Clinic in biomanufacturing to deliver novel biotherapeutics for rare and complex conditions.
Charles River Laboratories, International Inc. has received regulatory approval - in the form of Good Manufacturing Practice (GMP) certification - to commercially produce allogeneic cell therapy drug products for distribution in Europe, from the European...
A $76m investment in the facility in Grand Island, New York, will increase capacity to produce raw materials used in manufacture of vaccines and biologic therapies.
The US Centers for Disease Control and Prevention (CDC) says COVID-19 has ‘pushed back years of progress’ in combating antimicrobial resistance (AR) in the US – adding that the threat from AR has also got worse.
People with HIV who began taking antiretroviral therapy (ART) in the early stages of infection achieved a lengthy period of HIV suppression without ART after receiving two broadly neutralizing anti-HIV antibodies (bNAbs), according to a study published...
The US Food and Drug Administration (FDA) has approved GSK’s Priorix (Measles, Mumps and Rubella Vaccine, Live) for individuals 12 months of age and older.
The agreement, which was made in coordination between the US army and BARDA, will see Jubilant expand its injectable filling production capacity to prepare for future pandemics.
Eli Lilly and Company plans to expand its manufacturing footprint in Indiana by investing $2.1bn in two new manufacturing sites at Indiana's LEAP Lebanon Innovation and Research District in Boone County.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, has awarded a total of $577m to establish nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern.
A survey from Spherix gathered reactions from US neurologists after the US Centers for Medicare & Medicaid Services (CMS) announced its National Coverage Determination for monoclonal antibodies against amyloid for the treatment of Alzheimer’s.
